In biotechnology, pharmaceutical, medical-device, and related industries, cleanliness of surfaces and equipment is a critical issue. It can be very difficult to ascertain whether a proper amount of cleaning has been performed and/or maintained.
One current problem with cleaning validation sampling is human error and inconsistent execution. This issue is most seen in hard to reach areas such as inside tanks or vessels. Companies spend considerable amounts of time and money training and certifying individuals to perform swabbing. Even with a lot of training there is no guarantee that the sample will not yield a false passing result, since not enough surface was swabbed or they did not apply the correct amount of pressure. Even with the use of highly trained validation specialists, there is a significant risk of generating false positive or negative results due to variability in a number of factors including but not limited to actual swabbed surface area or actual pressure applied to the surface.
Confined space entry to perform swabbing is dangerous. Multiple people are needed (three minimum) to ensure the safety of the person swabbing the vessel. If swabbing is performed by use of a telescoping pole as opposed to vessel entry, then the risk of not properly performing the sampling increases due to the distance between the person controlling the swab and the swab location.